PresbyopiaPhase 3NCT05753189
Phase 3 Safety Study of LNZ100 and LNZ101 for the Treatment of Presbyopia Subjects
A Phase 3 study testing Aceclidine+Brimonidine combination ophthalmic solution and Aceclidine ophthalmic solution in people with Presbyopia and Near Vision, run by LENZ Therapeutics, Inc at 40 sites in United States.
Trial summary
Safety Study of the Long-Term Safety of LNZ100 \& LNZ101 in Presbyopic Subjects Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Presbyopia, Near Vision, Refractive Error
- What is being tested?
- Aceclidine+Brimonidine combination ophthalmic solution and Aceclidine ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- 40 sitesUnited States
- Study dates
- 21 Feb 2023to 9 Feb 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be able and willing to provide written informed consent and sign a Health Information Portability and Accountability Act (HIPAA) form prior to any study procedure being performed;
- Be able and willing to follow all instructions and attend all study visits;
- Be 45-75 years of age of either sex and any race or ethnicity at Visit 1;
- Have +1.00 to -4.00 diopter (D) of sphere calculated in minus cylinder (so that spherical equivalent (SE) results in myopia no more severe than -4.00 D MRSE) in both eyes determined by manifest refraction documented at Visit 1;
- Have ≤2.00 D of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at Visit 1;
- Be presbyopic as determined at Visit 1
Who cannot join
- Be a female of childbearing potential who is currently pregnant, nursing, or planning a pregnancy;
- Have known contraindications or sensitivity to the use of any of the study medications or their components;
- Have an active ocular infection at Visit 1 or at Visit 2 (bacterial, viral, or fungal), positive history of an ocular herpetic infection, preauricular lymphadenopathy, or ongoing, active ocular inflammation in either eye;
- Have moderate or severe dry eye defined as total central corneal fluorescein staining in either eye at Visit 1;
- Have clinically significant abnormal lens findings including early lens changes during dilated slit lamp biomicroscopy and fundus exam documented within 3 months of Visit 1 or at Visit 1
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
United States40 sites
Site #336
Alexandria, Minnesota, 56308
Site #335
Bozeman, Montana, 59718
Site #302
Chandler, Arizona, 85224
Site #329
Cincinnati, Ohio, 45242
Site #312
Cranberry Township, Pennsylvania, 16066
Site #319
Crystal River, Florida, 34429
Site #316
Danbury, Connecticut, 06810
Site #326
Dothan, Alabama, 36301
Site #341
Dover, New Jersey, 07801
Site #314
El Paso, Texas, 79902
Site #333
Eugene, Oregon, 97401
Site #310
Fargo, North Dakota, 58103
Site #303
Garden Grove, California, 92843
Site #313
Glendale, California, 91204
Site #330
Kansas City, Missouri, 64154
Site #334
La Jolla, California, 92037
Site #308
Littleton, Colorado, 80120
Site #324
Louisville, Kentucky, 40206
Site #315
Memphis, Tennessee, 38104
Site #320
Mesa, Arizona, 85202
Site #339
Morrow, Georgia, 30260
Site #309
Mt. Dora, Florida, 32757
Site #322
Newport Beach, California, 92663
Site #340
Northbrook, Illinois, 60062
Site #301
Overland Park, Kansas, 66210
Site #306
Petaluma, California, 94954
Site #321
Phoenix, Arizona, 85032
Site #328
Phoenix, Arizona, 85053
Site #307
Pittsburg, Kansas, 66762
Site #323
Powell, Ohio, 43065
Site #337
Rancho Cordova, California, 95670
Site #317
Rock Island, Illinois, 61201
Site #318
San Antonio, Texas, 78229
Site #327
San Antonio, Texas, 78229
Site #304
Santa Barbara, California, 93105
Site #338
Scottsdale, Arizona, 85260
Site #311
Smyrna, Tennessee, 37167
Site #325
St Louis, Missouri, 63128
Site #331
Sun City, Arizona, 85351
Site #332
West Fargo, North Dakota, 58078
About this study
Official title: Safety Study: A Multi-Center, Double-Masked Phase 3 Safety Study Evaluation of the Long-Term Safety of LNZ101 in Presbyopic Subjects
Safety Study of the Long-Term Safety of LNZ100 \& LNZ101 in Presbyopic Subjects
Read the detailed description
Safety Study: Multi-Center, Double-Masked Phase 3 Evaluation of the Long-Term Safety of LNZ101 compared with LNZ100 in Presbyopic Subjects
- Conditions
- Presbyopia, Near Vision, Refractive Error, Eye Diseases
- Being tested
- Aceclidine+Brimonidine combination ophthalmic solution, Aceclidine ophthalmic solution, Vehicle
- Keywords
- Pharmaceutical Solutions, Opthalmic Solutions, Eye Drops, CLARITY, Presbyopia, Miotics
- Medical subject headings
- Presbyopia, Myopia, Refractive Errors, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aceclidine+Brimonidine combination ophthalmic solutionDrug
Also called LNZ101
Aceclidine + Brimonidine combination ophthalmic solution
Aceclidine ophthalmic solutionDrug
Also called LNZ100
Aceclidine ophthalmic solution
VehicleDrug
Also called Proprietary vehicle ophthalmic solution
Vehicle
| Study group | Role | What they receive |
|---|---|---|
| Aceclidine + Brimonidine (LNZ101) dosed bilaterally | Experimental | LNZ101: Aceclidine + Brimonidine ophthalmic solution Receives: Drug: Aceclidine+Brimonidine combination ophthalmic solution |
| Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally | Experimental | LNZ100: Aceclidine ophthalmic solution Receives: Drug: Aceclidine ophthalmic solution |
| Vehicle Ophthalmic Solution dosed bilaterally | Experimental | Vehicle ophthalmic solution Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With at Least One Treatment-Related TEAE
Number and Percentage of Participants with at least one Treatment-Related Treatment-Emergent Adverse Events (TEAE) were collected by systematic assessment and coded using MedDRA.
Measured: 7 visits over a total duration of approximately 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start21 Feb 2023
- Primary completion9 Feb 2024
- Study completion9 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Multi-Center, Double-Masked Phase 3 Evaluation of the Long-Term Safety of LNZ100 \& LNZ101 in Presbyopic Subjects
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- LENZ Therapeutics, Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kris Gambelin, BS, Study director, LENZ Therapeutics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753189
- Sponsor's protocol ID
- 22-150-0017
- Status last verified
- May 2026
- First submitted
- 7 Feb 2023
- Last updated
- 13 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study: A Multi-Center, Double-Masked Phase 3 Safety Study Evaluation of the Long-Term Safety of LNZ101 in Presbyopic Subjects
- ClinicalTrials.gov ID
- NCT05753189
- Acronym / sponsor ID
- 22-150-0017
- Conditions
- Presbyopia, Near Vision, Refractive Error, Eye Diseases
- Keywords
- Pharmaceutical Solutions, Opthalmic Solutions, Eye Drops, CLARITY, Presbyopia, Miotics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- LENZ Therapeutics, IncUniversity, hospital or other
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 9 Feb 2024 (actual)
- Study completion
- 9 Feb 2024 (actual)
- First posted
- 3 Mar 2023 (actual)
- Results
- Posted 13 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety Study of the Long-Term Safety of LNZ100 \& LNZ101 in Presbyopic Subjects
Detailed description
Safety Study: Multi-Center, Double-Masked Phase 3 Evaluation of the Long-Term Safety of LNZ101 compared with LNZ100 in Presbyopic Subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- A Multi-Center, Double-Masked Phase 3 Evaluation of the Long-Term Safety of LNZ100 \& LNZ101 in Presbyopic Subjects
| Arm | Type | Receives |
|---|---|---|
| Aceclidine + Brimonidine (LNZ101) dosed bilaterally | Experimental | Drug: Aceclidine+Brimonidine combination ophthalmic solutionLNZ101: Aceclidine + Brimonidine ophthalmic solution |
| Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally | Experimental | Drug: Aceclidine ophthalmic solutionLNZ100: Aceclidine ophthalmic solution |
| Vehicle Ophthalmic Solution dosed bilaterally | Experimental | Drug: VehicleVehicle ophthalmic solution |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be able and willing to provide written informed consent and sign a Health Information Portability and Accountability Act (HIPAA) form prior to any study procedure being performed;
- Be able and willing to follow all instructions and attend all study visits;
- Be 45-75 years of age of either sex and any race or ethnicity at Visit 1;
- Have +1.00 to -4.00 diopter (D) of sphere calculated in minus cylinder (so that spherical equivalent (SE) results in myopia no more severe than -4.00 D MRSE) in both eyes determined by manifest refraction documented at Visit 1;
- Have ≤2.00 D of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at Visit 1;
Key exclusion criteria (5 listed)
- Be a female of childbearing potential who is currently pregnant, nursing, or planning a pregnancy;
- Have known contraindications or sensitivity to the use of any of the study medications or their components;
- Have an active ocular infection at Visit 1 or at Visit 2 (bacterial, viral, or fungal), positive history of an ocular herpetic infection, preauricular lymphadenopathy, or ongoing, active ocular inflammation in either eye;
- Have moderate or severe dry eye defined as total central corneal fluorescein staining in either eye at Visit 1;
- Have clinically significant abnormal lens findings including early lens changes during dilated slit lamp biomicroscopy and fundus exam documented within 3 months of Visit 1 or at Visit 1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aceclidine+Brimonidine combination ophthalmic solutionAlso: LNZ101Aceclidine + Brimonidine combination ophthalmic solution | Drug | Aceclidine + Brimonidine (LNZ101) dosed bilaterally |
| Aceclidine ophthalmic solutionAlso: LNZ100Aceclidine ophthalmic solution | Drug | Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally |
| VehicleAlso: Proprietary vehicle ophthalmic solutionVehicle | Drug | Vehicle Ophthalmic Solution dosed bilaterally |
Primary outcome
Number of Participants With at Least One Treatment-Related TEAE
Time frame: 7 visits over a total duration of approximately 28 weeks
Number and Percentage of Participants with at least one Treatment-Related Treatment-Emergent Adverse Events (TEAE) were collected by systematic assessment and coded using MedDRA.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kris Gambelin, BS study director
LENZ Therapeutics, Inc
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aceclidine+Brimonidine combination ophthalmic solution and Aceclidine ophthalmic solution in people with Presbyopia and Near Vision, run by LENZ Therapeutics, Inc at 40 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With at Least One Treatment-Related TEAE (time frame: 7 visits over a total duration of approximately 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.